Clinical Investigations

Since 1967, RII was charged with responsibilities for conducting clinical investigations of novel antiviral drugs and vaccines. Vast experience, gained in the trials, allowed for developing efficient approaches of preventing and treating viral infections. Many tested medications, such as Rimantadine, Arbidol, Ingaron, etc., live and inactivated influenza vaccines were successfully integrated into clinical practice.

Currently, RII is authorized by the Ministry of Health and Social Development of the Russian Federation, to carry out clinical trials of novel medical products and technologies. The investigations are organized and conducted within the two divisions of the Clinical Department — Specialized Clinic for Viral Infections and Division of Clinical and Experimental Investigations, the latter being a test ground for both preclinical and clinical evaluation of antiviral medications.

RII fully meets the requirements to maintain high quality phase I to IV clinical trials. State-of-the-art facilities and a team of professional physicians, clinical and laboratory investigators, nurses, epidemiologists, biostatisticians and IT—specialists, involved in the trials, ensures safety and efficiency of clinical research. All the investigations are carried out in close collaboration with RII research laboratories. To protect both volunteers and researchers, WHO guidelines and Good Clinical and Laboratory Practice (GCP and GLP) regulations are closely followed, while appropriate ethical and quality standards are guaranteed by an independent Ethics Committee.

Along with trials of RII—designed medicines, RII contributes to single— and multi—center national and international clinical research projects, provides expert services to various research institutions and pharmaceutical companies.

List of Vaccines Tested at RII

Research Period

Vaccine

Since 1985,
annually

Vaccine candidates for production of live influenza vaccine based on WHO-recommended seasonal strains